MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHzLanguage: English | Size: 331 MB | Duration: 54m
USFDA, ESG, eCTD, PSUR, Electronic communication, Data submission tool, Regulatory affairs,
What you'll learn
USFDA-Electronic submission gateway
Submission of electronic information to USFDA
Submission of eCTD through online submission tool
Preparation activities for submission
Application for account generation
Regulatory affairs
Guidance for Approval of Pharmaceutical Product
Generic pharmaceutical product registration
Electronic communication between USFDA and Applicant
Requirements
Pharmacy Profession
Regulatory affairs associate
Pharmaceutical industry Background
Curiosity towards learning
Science education
Description
If you Regulatory affairs profession and you are not aware about ESG (Electronic Submission gateway, then this course will make you specialist in handling regulatory hurdles.